New Guide for
Guide for the In Vivo Assessment of Bone Inductive Materials

WK16591

1. Scope

1.\tScope
1.1\tThis Standard Guide for the Assessment of Bone Forming Materials covers general guidelines to evaluate the effectiveness of devices intended to cause and/or promote bone formation when implanted or injected in vivo. This guide is applicable to devices that may be comprised of one or more of the following components: natural biomaterials (such as demineralized bone), synthetic biomaterials (such as calcium sulphate), cells, growth factors, cytokines, synthetic peptides or DNA. It should not be assumed that the devices evaluated using this guidance with a positive outcome will form bone when used in a clinical setting. It should be understood that the primary purpose of this guide is to facilitate the equitable comparison of unique bone forming devices in heterotopic in vivo models of osteoconductivity/ osteoinductivity/osteogenic activity.
1.2\tThis guide does not purport to address all of the safety concerns, if any, associated with the use of bone forming/promoting devices. It is the responsibility of the user of this guide to establish appropriate health and safety practices involved in the development of said devices in accordance with applicable regulatory guidance documents and in implementing this guide to evaluate the bone forming/promoting capabilities of the device.

This Guide will faciliate users in submitting 510(k)s to FDA and facilitate equitible conparison amoungst BVFs.

Keywords

bone void filler, DBM, athymic rodent

The title and scope are in draft form and are under development within this ASTM Committee.